Dropping ISO 9001 limits the scope of the ISO 13485 audit?

psp1234

Involved In Discussions
#1
Hi colleagues,
We are a contract manufacturer making 50% of our sales to medical device companies (and 50% to non-medical). We had 9001+13485 and last year we decided to drop 9001 due to the complexity of keeping both.
With no issues in last year's audit keeping the 13485, this year's auditor said he cannot look at non-medical products during the audit and cannot sample employees that do not handle medical components.
What does it mean to my non-medical customers?
What does it mean to our certification of "management system"? Is it concerning only to a portion of what we do?

appreciate some advise...
Thanks,
Sue
 
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somashekar

Staff member
Super Moderator
#2
Hi Sue.
If your ISO 9001 is a business requirement, then please address it with your CB and opt for both ISO 13485 and ISO 9001. Then it is up to the CB to quote and auditor to make the audit program suitably and cover the necessary man-days. Its very important that your scope is clear and different for both. Your QMS can be integrated and specifics of medical device can be suitably addressed.
 

indubioush

Quite Involved in Discussions
#3
Did you notify your non-medical customers that you were dropping the ISO 9001 cert? I hope so. If they do not care that you dropped the 9001 cert, then what is the problem with the auditor only auditing items that fall under the medical device scope? I guess my point is that you need to determine your customer requirements.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
What does it mean to my non-medical customers?
What does it mean to our certification of "management system"? Is it concerning only to a portion of what we do?
Those questions should have been reflected upon before the decision was made to drop ISO 9001 certification. The CB auditor is doing the right thing, auditing the system within the confines of the scope of certification.

Also, there should be no real burden to keep both certifications with a well designed quality system. The problem only exists if you "develop" the system mirroring the standards.
 

psp1234

Involved In Discussions
#5
Thank you all!
When opting out of 9001 I was following a CB-auditor's advise "off the records". I designed the QMS to address all products, but I didn't know that the registrar will not be looking at everything we do, but only at medical device related components. :confused:
Short question is: if I have medical and non-medical customers, must I run both 13485 and 9001?? (no way to use 13485 for all?) fyi - we are not making any finished devices, only components to OEMs.

ahh,
Sue
 

psp1234

Involved In Discussions
#6
Did you notify your non-medical customers that you were dropping the ISO 9001 cert? I hope so. If they do not care that you dropped the 9001 cert, then what is the problem with the auditor only auditing items that fall under the medical device scope? I guess my point is that you need to determine your customer requirements.
I did
 

indubioush

Quite Involved in Discussions
#7
If money was the issue with keeping both, and your non-medical customers are okay without the ISO 9001 cert, have the auditor look at only the medical stuff but continue to manage both medical and non-medical using the same processes. You can still do internal audits and audit everything yourself.

If money is not an issue, you should keep the ISO 9001 cert as this is the appropriate standard to follow for non-medical manufacturing. In some ways, the ISO 9001 standard is more advanced than ISO 13485, and following it would improve your business practices.
 
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